There’s a New Sheriff in Town, Are You Ready?

Congressional ire, in response to some well-publicized dietary supplement abuses, has given the Food and Drug Administration (FDA) the mandate to “clean up the supplement industry.” The newly appointed Commissioner of FDA, Dr. Margaret Hamburg, is accommodating these wishes by building a cadre of supplement industry critics including Ann Witt (formerly of Rep. Waxman’s staff, as was Dr. Joshua Sharfstein, now Dr. Hamburg’s Deputy Director) and, Peter Lurie and Sidney Wolfe, both of whom held positions at the anti-industry “Public Citizen’s Health Research Group” (as did Dr. Sharfstein). These appointments are unmistakable warnings to the supplement industry to get its house in order!

The history of FDA actions on dietary supplements gives some credence to the rumor that early on in the implementation of the Dietary Supplement Health and Education Act (DSHEA), the highest priority was to enforce stringent safety standards for New Dietary Ingredient Notifications (NDIN), but little other action was taken, with the anticipation the industry would implode as the result of reckless behavior by the “bottom feeders.” It appears few resources were committed to policing retail shelves and, as the result of only a few actions taken at the finished product level, many in the industry felt confident that either there was no intent to enforce and/or that there were “gray areas” in regulations – wrong on both counts! FDA was probably not given the resources to look at shelves and the perceived “gray areas” exist only in the imaginations of the naïve and the wishful thinkers – regulations for dietary supplements have few gray areas and dietary supplements are, in fact, more highly regulated than food ingredients!

On October 22, 2009, at the Council for Responsible Nutrition’s (CRN) annual meeting, Dr. Sharfstein indicated that too many supplements were spiked with drugs and/or substances that were not eligible for the grandfather exemption (i.e., marketed as a supplement prior to October 15, 1994). He also indicated that companies (presumably including your competitors) could report violative products to FDA via the reportable food registry. Further, he promised that FDA would use all the tools granted it under DSHEA, including strict enforcement of the 75-day pre-market notification requirement and removal of products from the market that failed to comply.